Trial Outcomes & Findings for Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children (NCT NCT00528957)

Results Overview

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

97 participants

Primary outcome timeframe

48 weeks

Results posted on

2018-03-14

Participant Flow

Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.

127 participants were screened.

Participant milestones

Participant milestones
Measure	Tenofovir DF Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	Stavudine or Zidovudine Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
Randomized Phase (Baseline to Week 48) STARTED	48	49
Randomized Phase (Baseline to Week 48) COMPLETED	44	48
Randomized Phase (Baseline to Week 48) NOT COMPLETED	4	1
First Extension (Week 48 to Week 144) STARTED	38	41
First Extension (Week 48 to Week 144) COMPLETED	35	40
First Extension (Week 48 to Week 144) NOT COMPLETED	3	1
Second Extension (Week 144 to Week 240) STARTED	34	40
Second Extension (Week 144 to Week 240) COMPLETED	27	37
Second Extension (Week 144 to Week 240) NOT COMPLETED	7	3
Third Extension (Week 240 to Week 336) STARTED	27	37
Third Extension (Week 240 to Week 336) COMPLETED	21	27
Third Extension (Week 240 to Week 336) NOT COMPLETED	6	10
Long-Term Extension (Week 336 and On) STARTED	19	25
Long-Term Extension (Week 336 and On) COMPLETED	9	8
Long-Term Extension (Week 336 and On) NOT COMPLETED	10	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenofovir DF Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	Stavudine or Zidovudine Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
Randomized Phase (Baseline to Week 48) Withdrew Consent	2	1
Randomized Phase (Baseline to Week 48) Safety, Tolerability, or Efficacy Reason	2	0
First Extension (Week 48 to Week 144) Investigator's Discretion	2	0
First Extension (Week 48 to Week 144) Safety, Tolerability, or Efficacy Reason	1	0
First Extension (Week 48 to Week 144) Withdrew Consent	0	1
Second Extension (Week 144 to Week 240) Safety, Tolerability, or Efficacy Reason	4	3
Second Extension (Week 144 to Week 240) Investigator's Discretion	3	0
Third Extension (Week 240 to Week 336) Safety, Tolerability, or Efficacy Reason	5	4
Third Extension (Week 240 to Week 336) Lost to Follow-up	0	3
Third Extension (Week 240 to Week 336) = 18 yr old & TDF approved in adults	1	1
Third Extension (Week 240 to Week 336) Investigator's Discretion	0	1
Third Extension (Week 240 to Week 336) Withdrew Consent	0	1
Long-Term Extension (Week 336 and On) Rolled Over to Study GS-US-311-1269	4	10
Long-Term Extension (Week 336 and On) Safety, Tolerability, or Efficacy Reason	3	5
Long-Term Extension (Week 336 and On) Withdrew Consent	2	1
Long-Term Extension (Week 336 and On) Investigator's Discretion	1	1

Baseline Characteristics

Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenofovir DF n=48 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	Stavudine or Zidovudine n=49 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	Total n=97 Participants Total of all reporting groups
Age, Continuous	7 years STANDARD_DEVIATION 3.3 • n=5 Participants	7 years STANDARD_DEVIATION 2.6 • n=7 Participants	7 years STANDARD_DEVIATION 3.0 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Mestizo	28 Participants n=5 Participants	37 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Native Indian (Kuna)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Panama	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Height	118 cm STANDARD_DEVIATION 19.8 • n=5 Participants	119 cm STANDARD_DEVIATION 16.7 • n=7 Participants	119 cm STANDARD_DEVIATION 18.2 • n=5 Participants
Body Mass Index	17.59 kg/m^2 STANDARD_DEVIATION 3.680 • n=5 Participants	16.59 kg/m^2 STANDARD_DEVIATION 1.762 • n=7 Participants	17.08 kg/m^2 STANDARD_DEVIATION 2.905 • n=5 Participants
Weight	25.9 kilograms STANDARD_DEVIATION 12.03 • n=5 Participants	24.1 kilograms STANDARD_DEVIATION 7.77 • n=7 Participants	25.0 kilograms STANDARD_DEVIATION 10.09 • n=5 Participants
Plasma HIV-1 RNA < 50 copies/mL	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Plasma HIV-1 RNA 50 to < 400 copies/mL	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Plasma HIV-1 RNA 400 to < 1000 copies/mL	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Plasma HIV-1 RNA ≥ 1000 copies/mL	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
CD4 Cell Count	1190 cells/mm^3 STANDARD_DEVIATION 541.7 • n=5 Participants	1144 cells/mm^3 STANDARD_DEVIATION 388.4 • n=7 Participants	1167 cells/mm^3 STANDARD_DEVIATION 468.6 • n=5 Participants
CD4 Percentage	33.9 percentage STANDARD_DEVIATION 7.44 • n=5 Participants	33.0 percentage STANDARD_DEVIATION 6.82 • n=7 Participants	33.5 percentage STANDARD_DEVIATION 7.11 • n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Intent-to-treat, Missing = Failure

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=48 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=49 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=89 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48	83.3 percentage of participants Interval 69.8 to 92.5	91.8 percentage of participants Interval 80.4 to 97.7	85.4 percentage of participants Interval 76.3 to 92.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Intent-to-treat (ITT) Analysis Set; only includes participants \< 12 years of age at baseline

This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=44 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=48 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF All participants who received tenofovir DF in the randomized and/or extension phases
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)	88.6 percentage of participants	89.6 percentage of participants	—

SECONDARY outcome

Timeframe: 48 weeks

Population: Intent-to-treat (ITT) Analysis Set; only includes participants \< 12 years of age at baseline

This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=44 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=48 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF All participants who received tenofovir DF in the randomized and/or extension phases
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)	75.0 percentage of participants	81.3 percentage of participants	—

SECONDARY outcome

Timeframe: 96 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 96 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=38 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=41 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=79 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96	81.6 percentage of participants	85.4 percentage of participants	83.5 percentage of participants

SECONDARY outcome

Timeframe: 144 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 144 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=38 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=40 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=78 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144	73.7 percentage of participants	87.5 percentage of participants	80.8 percentage of participants

SECONDARY outcome

Timeframe: 192 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 192 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=34 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=40 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=74 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks	70.6 percentage of participants	82.5 percentage of participants	77.0 percentage of participants

SECONDARY outcome

Timeframe: 240 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 240 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=34 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=71 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks	70.6 percentage of participants	75.7 percentage of participants	73.2 percentage of participants

SECONDARY outcome

Timeframe: 288 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 288 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=27 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=64 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks	81.5 percentage of participants	67.6 percentage of participants	73.4 percentage of participants

SECONDARY outcome

Timeframe: 336 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 336 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=22 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=21 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=43 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks	90.9 percentage of participants	100.0 percentage of participants	95.3 percentage of participants

SECONDARY outcome

Timeframe: 384 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 384 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=17 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=9 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=26 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: 432 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 432 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=13 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=7 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=20 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks	100.0 percentage of participants	85.7 percentage of participants	95.0 percentage of participants

SECONDARY outcome

Timeframe: 480 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 480 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=9 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=2 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=11 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks	88.9 percentage of participants	100.0 percentage of participants	90.9 percentage of participants

SECONDARY outcome

Timeframe: 528 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 528 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=6 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=6 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks	100.0 percentage of participants	—	100.0 percentage of participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 48 weeks of exposure to randomized study drug.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=48 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=49 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=89 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks	70.8 percentage of participants	85.7 percentage of participants	68.5 percentage of participants

SECONDARY outcome

Timeframe: 96 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 96 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=38 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=41 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=79 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks	76.3 percentage of participants	68.3 percentage of participants	72.2 percentage of participants

SECONDARY outcome

Timeframe: 144 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 144 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=38 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=40 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=78 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks	63.2 percentage of participants	75.0 percentage of participants	69.2 percentage of participants

SECONDARY outcome

Timeframe: 192 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 192 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=34 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=40 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=74 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks	67.6 percentage of participants	75.0 percentage of participants	71.6 percentage of participants

SECONDARY outcome

Timeframe: 240 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 240 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=34 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=71 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks	70.6 percentage of participants	73.0 percentage of participants	71.8 percentage of participants

SECONDARY outcome

Timeframe: 288 weeks

Population: Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 288 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=27 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=64 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks	81.5 percentage of participants	62.2 percentage of participants	70.3 percentage of participants

SECONDARY outcome

Timeframe: 336 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 336 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=22 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=21 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=43 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks	86.4 percentage of participants	90.5 percentage of participants	88.4 percentage of participants

SECONDARY outcome

Timeframe: 384 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 384 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=17 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=9 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=26 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks	88.2 percentage of participants	100.0 percentage of participants	92.3 percentage of participants

SECONDARY outcome

Timeframe: 432 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 432 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=13 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=7 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=20 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks	100.0 percentage of participants	71.4 percentage of participants	90.0 percentage of participants

SECONDARY outcome

Timeframe: 480 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 480 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=9 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=2 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=11 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks	77.8 percentage of participants	50.0 percentage of participants	72.7 percentage of participants

SECONDARY outcome

Timeframe: 528 weeks

Population: Intent-to-treat, Missing = Excluded

This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 528 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=6 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=6 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks	100.0 percentage of participants	—	100.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=46 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=48 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=86 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 48 Weeks	0.3 percentage Standard Deviation 4.49	1.1 percentage Standard Deviation 4.73	0.6 percentage Standard Deviation 3.85

SECONDARY outcome

Timeframe: Baseline and 96 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=37 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=38 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=75 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 96 Weeks	1.3 percentage Standard Deviation 4.08	-0.1 percentage Standard Deviation 3.60	0.6 percentage Standard Deviation 3.88

SECONDARY outcome

Timeframe: Baseline and 144 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=33 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=38 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=71 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 144 Weeks	0.8 percentage Standard Deviation 5.61	-0.1 percentage Standard Deviation 3.83	0.3 percentage Standard Deviation 4.73

SECONDARY outcome

Timeframe: Baseline and 192 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=29 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=66 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 192 Weeks	1.1 percentage Standard Deviation 5.57	0.6 percentage Standard Deviation 3.69	0.8 percentage Standard Deviation 4.58

SECONDARY outcome

Timeframe: Baseline and 240 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=28 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=32 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=60 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 240 Weeks	1.3 percentage Standard Deviation 5.98	-0.9 percentage Standard Deviation 4.13	0.1 percentage Standard Deviation 5.16

SECONDARY outcome

Timeframe: Baseline and 288 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=26 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=26 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=52 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 288 Weeks	2.0 percentage Standard Deviation 6.30	0.5 percentage Standard Deviation 4.77	1.3 percentage Standard Deviation 5.58

SECONDARY outcome

Timeframe: Baseline and 336 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=23 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=22 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=45 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 336 Weeks	2.0 percentage Standard Deviation 7.19	0.8 percentage Standard Deviation 4.01	1.4 percentage Standard Deviation 5.82

SECONDARY outcome

Timeframe: Baseline and 384 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=19 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=10 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=29 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 384 Weeks	0.5 percentage Standard Deviation 7.80	1.6 percentage Standard Deviation 1.90	0.9 percentage Standard Deviation 6.37

SECONDARY outcome

Timeframe: Baseline and 432 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=14 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=7 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=21 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 432 Weeks	0.3 percentage Standard Deviation 6.41	2.9 percentage Standard Deviation 3.53	1.1 percentage Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline and 480 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=10 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=3 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=13 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 480 Weeks	2.3 percentage Standard Deviation 7.15	5.0 percentage Standard Deviation 10.00	2.9 percentage Standard Deviation 7.51

SECONDARY outcome

Timeframe: Baseline and 528 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=6 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=6 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Percentage at 528 Weeks	4.5 percentage Standard Deviation 3.89	—	4.5 percentage Standard Deviation 3.89

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=46 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=48 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=86 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks	-97 cells/mm^3 Standard Deviation 416.4	-11 cells/mm^3 Standard Deviation 280.2	2 cells/mm^3 Standard Deviation 385.9

SECONDARY outcome

Timeframe: Baseline and 96 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=37 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=74 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks	-77 cells/mm^3 Standard Deviation 408.3	-56 cells/mm^3 Standard Deviation 305.6	-67 cells/mm^3 Standard Deviation 358.3

SECONDARY outcome

Timeframe: Baseline and 144 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=33 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=38 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=71 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks	-139 cells/mm^3 Standard Deviation 438.2	-146 cells/mm^3 Standard Deviation 245.3	-142 cells/mm^3 Standard Deviation 345.9

SECONDARY outcome

Timeframe: Baseline and 192 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=29 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=37 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=66 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks	-304 cells/mm^3 Standard Deviation 529.0	-177 cells/mm^3 Standard Deviation 288.5	-233 cells/mm^3 Standard Deviation 413.2

SECONDARY outcome

Timeframe: Baseline and 240 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=27 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=32 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=59 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks	-369 cells/mm^3 Standard Deviation 529.9	-296 cells/mm^3 Standard Deviation 252.6	-329 cells/mm^3 Standard Deviation 401.7

SECONDARY outcome

Timeframe: Baseline and 288 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=26 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=25 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=51 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks	-346 cells/mm^3 Standard Deviation 507.5	-256 cells/mm^3 Standard Deviation 292.5	-302 cells/mm^3 Standard Deviation 414.6

SECONDARY outcome

Timeframe: Baseline and 336 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=23 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=22 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=45 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks	-415 cells/mm^3 Standard Deviation 569.4	-283 cells/mm^3 Standard Deviation 252.2	-350 cells/mm^3 Standard Deviation 443.8

SECONDARY outcome

Timeframe: Baseline and 384 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=19 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=10 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=29 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks	-620 cells/mm^3 Standard Deviation 635.6	-305 cells/mm^3 Standard Deviation 238.2	-512 cells/mm^3 Standard Deviation 548.8

SECONDARY outcome

Timeframe: Baseline and 432 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=14 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=7 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=21 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks	-795 cells/mm^3 Standard Deviation 559.2	-302 cells/mm^3 Standard Deviation 355.2	-631 cells/mm^3 Standard Deviation 545.7

SECONDARY outcome

Timeframe: Baseline and 480 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=10 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF n=3 Participants Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=13 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks	-923 cells/mm^3 Standard Deviation 755.4	-448 cells/mm^3 Standard Deviation 469.9	-813 cells/mm^3 Standard Deviation 712.9

SECONDARY outcome

Timeframe: Baseline and 528 weeks

Population: Intent-to-treat, Missing = Excluded

This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=6 Participants Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).	(Stavudine or Zidovudine)/TDF Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).	All TDF n=6 Participants All participants who received tenofovir DF in the randomized and/or extension phases
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks	-710 cells/mm^3 Standard Deviation 447.0	—	-710 cells/mm^3 Standard Deviation 447.0

Adverse Events

Tenofovir DF

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Stavudine or Zidovudine

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

All TDF

Serious events: 15 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Disclosures & Transparency

Gilead Sciences

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER