Trial · NCT00342355
Antiretroviral Therapy for Advanced HIV Disease in South Africa
NCT00342355, Phase 4, Completed, National Institutes of Health Clinical Center (CC); results first posted 2013-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antiretroviral Therapy for Advanced HIV Disease in South Africa. Trials, record NCT00342355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00342355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiretroviral Therapy for Advanced HIV Disease in South Africa
- NCT number
- NCT00342355
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,771 participants, actual
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Conditions
- HIV
- Interventions
- Zidovudine, Stavudine, Didanosine, Lamivudine, Efavirenz, Lopinavir/Ritonavir
- First posted
- 2006-06-21
- Last updated
- 2013-05-21
- Results first posted
- 2013-04-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | January 2004 until March 31 2008 | Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens. |
| Secondary | Serious Adverse Events | January 2004 until March 31, 2008 | Safety outcomes in four different randomly assigned regimens |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Serious Adverse Events | January 2004 until March 31, 2008 | participant | NUMBER | |
| PRIMARY | Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | January 2004 until March 31 2008 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serious Adverse Events | AZT+ddI+EFV | 73 | participant | ||
| Serious Adverse Events | AZT + ddI + r/LPV | 69 | participant | ||
| Serious Adverse Events | d4T + 3TC + EFV | 64 | participant | ||
| Serious Adverse Events | d4T + 3TC + r/LPV | 60 | participant | ||
| Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | AZT+ddI+EFV | 93 | participants | ||
| Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | AZT + ddI + r/LPV | 77 | participants | ||
| Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | d4T + 3TC + EFV | 70 | participants | ||
| Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. | d4T + 3TC + r/LPV | 80 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZT+ddI+EFV | 444 | |
| Overall Study | STARTED | AZT + ddI + r/LPV | 440 | |
| Overall Study | STARTED | d4T + 3TC + EFV | 444 | |
| Overall Study | STARTED | d4T + 3TC + r/LPV | 443 | |
| Overall Study | COMPLETED | AZT+ddI+EFV | 444 | |
| Overall Study | COMPLETED | AZT + ddI + r/LPV | 440 | |
| Overall Study | COMPLETED | d4T + 3TC + EFV | 444 | |
| Overall Study | COMPLETED | d4T + 3TC + r/LPV | 443 | |
| Overall Study | NOT COMPLETED | AZT+ddI+EFV | 0 | |
| Overall Study | NOT COMPLETED | AZT + ddI + r/LPV | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | AZT+ddI+EFV | 12 | 444 | 12 |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | AZT + ddI + r/LPV | 9 | 440 | 9 |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | d4T + 3TC + EFV | 5 | 444 | 5 |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | d4T + 3TC + r/LPV | 2 | 443 | 2 |
| serious | Gastrointestinal | Gastrointestinal disorders | AZT+ddI+EFV | 21 | 444 | 21 |
| serious | Gastrointestinal | Gastrointestinal disorders | AZT + ddI + r/LPV | 15 | 440 | 15 |
| serious | Gastrointestinal | Gastrointestinal disorders | d4T + 3TC + EFV | 10 | 444 | 10 |
| serious | Gastrointestinal | Gastrointestinal disorders | d4T + 3TC + r/LPV | 15 | 443 | 15 |
| serious | General Disorders | General disorders | AZT+ddI+EFV | 7 | 444 | 7 |
| serious | General Disorders | General disorders | AZT + ddI + r/LPV | 6 | 440 | 6 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZT+ddI+EFV | ||
| Total, all-cause mortality | AZT + ddI + r/LPV | ||
| Total, all-cause mortality | d4T + 3TC + EFV | ||
| Total, all-cause mortality | d4T + 3TC + r/LPV | ||
| Total, other adverse events | AZT+ddI+EFV | 0 | 444 |
| Total, other adverse events | AZT + ddI + r/LPV | 0 | 440 |
| Total, other adverse events | d4T + 3TC + EFV | 0 | 444 |
| Total, other adverse events | d4T + 3TC + r/LPV | 0 | 443 |
| Total, serious adverse events | AZT+ddI+EFV | 96 | 444 |
| Total, serious adverse events | AZT + ddI + r/LPV | 85 | 440 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00342355
GET https://conductscience.org/api/trials/v1/NCT00342355/events?page=2