Trial Outcomes & Findings for Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities (NCT NCT00255840)
NCT ID: NCT00255840
Last Updated: 2011-06-21
Results Overview
Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
812 participants
Primary outcome timeframe
96 weeks
Results posted on
2011-06-21
Participant Flow
HIV-positive adult participants were recruited from February 2005 to December 2007 from two primary health care clinics, one in Masiphumelele, Cape Town and the other in Soweto, Johannesburg.
Participant milestones
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
408
|
404
|
|
Overall Study
COMPLETED
|
345
|
334
|
|
Overall Study
NOT COMPLETED
|
63
|
70
|
Reasons for withdrawal
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
14
|
|
Overall Study
Discontinued intervention
|
53
|
56
|
Baseline Characteristics
Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
Baseline characteristics by cohort
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
n=408 Participants
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
n=404 Participants
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Total
n=812 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
|
408 Participants
n=5 Participants
|
404 Participants
n=7 Participants
|
812 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
|
33.2612388 years
STANDARD_DEVIATION 7.1934154 • n=5 Participants
|
32.9739630 years
STANDARD_DEVIATION 7.3921786 • n=7 Participants
|
33.12 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
573 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
408 participants
n=5 Participants
|
404 participants
n=7 Participants
|
812 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.
Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
Outcome measures
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
n=408 Participants
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
n=404 Participants
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
|---|---|---|
|
Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).
|
44 Percentage of participants
Interval 39.0 to 49.0
|
48 Percentage of participants
Interval 43.0 to 52.0
|
SECONDARY outcome
Timeframe: Throughout studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout studyOutcome measures
Outcome data not reported
Adverse Events
Antiretroviral Therapy Monitored by Medical Officer
Serious events: 126 serious events
Other events: 194 other events
Deaths: 0 deaths
Antiretroviral Therapy Managed by Primary Health Care Nurse
Serious events: 153 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
n=408 participants at risk
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
n=404 participants at risk
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
|---|---|---|
|
General disorders
Weakness
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 2
|
|
Hepatobiliary disorders
Hepatitis
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.49%
2/408 • Number of events 2
|
0.00%
0/404
|
|
Immune system disorders
Immune Reconstitution Syndrome
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Abcess
|
0.00%
0/408
|
0.74%
3/404 • Number of events 4
|
|
Infections and infestations
Bronchopneumonia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Blood and lymphatic system disorders
Anemia
|
0.49%
2/408 • Number of events 2
|
0.50%
2/404 • Number of events 4
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.49%
2/408 • Number of events 2
|
1.7%
7/404 • Number of events 7
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal symptoms NOS
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.74%
3/408 • Number of events 3
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Right Upper Quadrant Pain
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Cardiac disorders
Congestive Heart Failure
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Eye disorders
Hyphema
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Gastrointestinal disorders
Diarrhea
|
0.49%
2/408 • Number of events 2
|
0.00%
0/404
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Gastrointestinal disorders
Ruptured Appendix
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
General disorders
Death
|
0.74%
3/408 • Number of events 3
|
0.25%
1/404 • Number of events 1
|
|
General disorders
Swelling of Legs
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Buboes
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Cerebral Toxoplasmosis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Chest Infection
|
0.00%
0/408
|
0.99%
4/404 • Number of events 4
|
|
Infections and infestations
Cryptococcal Meningitis
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Infections and infestations
Diarrhoea Cryptosporidial
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Gastroenteritis
|
0.74%
3/408 • Number of events 3
|
0.00%
0/404
|
|
Infections and infestations
Hidradenitis Suppurativa
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Joint Infection
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Lobar Pneumonia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.98%
4/408 • Number of events 4
|
0.25%
1/404 • Number of events 1
|
|
Infections and infestations
Meningitis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Perineal Abscess
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Infections and infestations
Pneumocystis Carnii Pneumonia
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.5%
6/408 • Number of events 6
|
0.99%
4/404 • Number of events 4
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.74%
3/408 • Number of events 3
|
0.50%
2/404 • Number of events 2
|
|
Infections and infestations
Respiratory Tract Infection
|
0.98%
4/408 • Number of events 4
|
0.00%
0/404
|
|
Infections and infestations
Tuberculosis Pleurisy
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Infections and infestations
Tuberculosis Meningitis
|
0.00%
0/408
|
0.74%
3/404 • Number of events 3
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
2/408 • Number of events 2
|
0.00%
0/404
|
|
Infections and infestations
Wound Sepsis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Injury, poisoning and procedural complications
Chemical Poisoning
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Injury, poisoning and procedural complications
Smoke Inhalation
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.49%
2/408 • Number of events 2
|
0.00%
0/404
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Investigations
Alkaline Phosphatase Increased
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Injury, poisoning and procedural complications
ALT Increased
|
1.7%
7/408 • Number of events 9
|
2.7%
11/404 • Number of events 12
|
|
Injury, poisoning and procedural complications
AST Increased
|
1.2%
5/408 • Number of events 5
|
2.5%
10/404 • Number of events 11
|
|
Investigations
GGT Increased
|
1.7%
7/408 • Number of events 8
|
1.5%
6/404 • Number of events 6
|
|
Investigations
Lipase Increased
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 3
|
|
Investigations
Loss of Weight
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Investigations
Lactate Increased
|
0.00%
0/408
|
0.50%
2/404 • Number of events 2
|
|
Investigations
Creatinine Increased
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlactataemia
|
0.74%
3/408 • Number of events 3
|
4.2%
17/404 • Number of events 17
|
|
Metabolism and nutrition disorders
Insulin Dependent Diabetic
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.2%
5/408 • Number of events 5
|
2.2%
9/404 • Number of events 9
|
|
Metabolism and nutrition disorders
Lipodystrophy
|
0.00%
0/408
|
1.7%
7/404 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Karposi's Sarcoma
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Nervous system disorders
Left Side Paralysis
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Nervous system disorders
Mental Retardation
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Nervous system disorders
Loss of Consciousness
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Nervous system disorders
Peripheral Neuropathy NOS
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum Haemorrhage
|
0.25%
1/408 • Number of events 1
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Pregnancy, puerperium and perinatal conditions
Abruptio Plancentae
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Pregnancy, puerperium and perinatal conditions
Eclampsia
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Death
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Hellp Syndrome
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Incomplete Abortion
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Normal Delivery
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/408
|
0.50%
2/404 • Number of events 2
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Reproductive system and breast disorders
Bartholin's Cyst
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.49%
2/408 • Number of events 2
|
0.25%
1/404 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/408
|
0.50%
2/404 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/408
|
0.50%
2/404 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Psychiatric disorders
Parasuicide
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Skin and subcutaneous tissue disorders
Bullous Rash
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Skin and subcutaneous tissue disorders
Drug Rash
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema Weeping
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Skin and subcutaneous tissue disorders
Seborrheic Dermatitis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Skin and subcutaneous tissue disorders
Stevens Johnson Syndrome
|
0.49%
2/408 • Number of events 2
|
0.00%
0/404
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Social circumstances
Assault
|
0.49%
2/408 • Number of events 2
|
0.25%
1/404 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Surgical and medical procedures
Hysterectomy
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Vascular disorders
Collapse Cardiovascular
|
0.25%
1/408 • Number of events 1
|
0.00%
0/404
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.25%
1/408 • Number of events 1
|
0.50%
2/404 • Number of events 2
|
|
Vascular disorders
Gangrene
|
0.00%
0/408
|
0.25%
1/404 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.49%
2/408 • Number of events 4
|
0.25%
1/404 • Number of events 1
|
Other adverse events
| Measure |
Antiretroviral Therapy Monitored by Medical Officer
n=408 participants at risk
First line antiretroviral regimen monitored by a HIV-trained medical doctor:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
Antiretroviral Therapy Managed by Primary Health Care Nurse
n=404 participants at risk
First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
1. Stavudine (\>60 kg: 40 mg twice daily and \<60 kg: 30 mg twice daily)
2. Lamivudine (150mg twice daily) and
3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count \<250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count \> 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.6%
27/408 • Number of events 34
|
4.2%
17/404 • Number of events 22
|
|
Investigations
GGT increased
|
7.1%
29/408 • Number of events 36
|
3.7%
15/404 • Number of events 20
|
|
Metabolism and nutrition disorders
Hyperlactatemia
|
17.4%
71/408 • Number of events 79
|
10.6%
43/404 • Number of events 44
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy
|
9.6%
39/408 • Number of events 40
|
8.4%
34/404 • Number of events 35
|
|
Nervous system disorders
Peripheral Neuropathy
|
6.9%
28/408 • Number of events 29
|
2.5%
10/404 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place