Trial Outcomes & Findings for GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (NCT NCT00808405)

Last Updated: 2013-12-11

Results Overview

To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Days 1-5, 7, 9, 11, 13

Results posted on

2013-12-11

Participant Flow

Between January and December 2009, women from Johannesburg, South Africa and Lusaka, Zambia who had previously participated in the HPTN 039 (NCT00076232) study, as well as other women in the community who presented to the research clinics with genetic ulcer disease (GUD) during the recruitment period, were invited to participate in the study.

Participant milestones

Participant milestones
Measure	Acyclovir Acyclovir 400 mg orally three times daily	Placebo Matching placebo tablet
Overall Study STARTED	61	27
Overall Study COMPLETED	61	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acyclovir n=61 Participants Acyclovir 400 mg orally three times daily	Placebo n=27 Participants Matching placebo tablet	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	27 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38.66 years STANDARD_DEVIATION 10.28 • n=5 Participants	38.15 years STANDARD_DEVIATION 10.31 • n=7 Participants	38.5 years STANDARD_DEVIATION 10.23 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	27 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Zambia	31 participants n=5 Participants	13 participants n=7 Participants	44 participants n=5 Participants
Region of Enrollment South Africa	30 participants n=5 Participants	14 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1-5, 7, 9, 11, 13

Population: Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.

To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo

Outcome measures

Outcome measures
Measure	Acyclovir n=61 Participants Acyclovir 400 mg orally three times daily	Placebo n=27 Participants Matching placebo tablet
Time to Healing of Genital Lesions	5.1 Days Standard Error 0.3	6.0 Days Standard Error 0.6

SECONDARY outcome

Timeframe: Days 1-5, 7, 9, 11, 13

Population: Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.

To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo

Outcome measures

Outcome measures
Measure	Acyclovir n=61 Participants Acyclovir 400 mg orally three times daily	Placebo n=27 Participants Matching placebo tablet
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR	3.0 Days Standard Error 0.3	5.0 Days Standard Error 0.8

Adverse Events

Acyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Connie Celum, MD, MPH

University of Washington

Phone: 206-520-3824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place