Trial · NCT00074581
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
NCT00074581, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preventing Sexual Transmission of HIV With Anti-HIV Drugs. Trials, record NCT00074581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00074581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventing Sexual Transmission of HIV With Anti-HIV Drugs
- NCT number
- NCT00074581
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,526 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Atazanavir, Didanosine, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Lamivudine, Lopinavir/Ritonavir, Nevirapine, Stavudine, Tenofovir disoproxil fumarate, Zidovudine/Lamivudine
- First posted
- 2003-12-17
- Last updated
- 2021-11-05
- Results first posted
- 2016-10-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Throughout study | incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner. |
| Primary | All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Throughout study | All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Throughout study | event rate per 100 person-yr | NUMBER | |
| PRIMARY | All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Throughout study | Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm. | event rate per 100 person-yr | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Early-ART | 0.07 | 95% Confidence Interval 0.01 to 0.20 | event rate per 100 person-yr | |
| Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Delayed-ART | 1.03 | 95% Confidence Interval 0.74 to 1.38 | event rate per 100 person-yr | |
| All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Early-ART | 0.44 | 95% Confidence Interval 0.26 to 0.69 | event rate per 100 person-yr | |
| All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms | Delayed-ART | 1.41 | 95% Confidence Interval 1.07 to 1.82 | event rate per 100 person-yr |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early-ART | 1,789 | |
| Overall Study | STARTED | Delayed-ART | 1,767 | |
| Overall Study | COMPLETED | Early-ART | 1,545 | |
| Overall Study | COMPLETED | Delayed-ART | 1,541 | |
| Overall Study | NOT COMPLETED | Early-ART | 244 | |
| Overall Study | NOT COMPLETED | Delayed-ART | 226 |
Source ClinicalTrials.gov
Adverse events734
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 | Anaemia | Blood and lymphatic system disorders | Early-ART | 15 | 886 | |
| serious | Anaemia | Blood and lymphatic system disorders | Delayed-ART | 19 | 877 | |
| serious | Anaemia of pregnancy | Blood and lymphatic system disorders | Early-ART | 1 | 886 | |
| serious | Anaemia of pregnancy | Blood and lymphatic system disorders | Delayed-ART | 1 | 877 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Early-ART | 0 | 886 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Delayed-ART | 1 | 877 | |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Early-ART | 1 | 886 | |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Delayed-ART | 0 | 877 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Early-ART | 1 | 886 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Delayed-ART | 0 | 877 |
1 to 10 of 734Source ClinicalTrials.gov
See all 734 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early-ART | ||
| Total, all-cause mortality | Delayed-ART | ||
| Total, other adverse events | Early-ART | 0 | 886 |
| Total, other adverse events | Delayed-ART | 0 | 877 |
| Total, serious adverse events | Early-ART | 526 | 886 |
| Total, serious adverse events | Delayed-ART | 522 | 877 |
Source ClinicalTrials.gov
Papers8
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Early-ART vs Delayed-ART: serious adverse events |
Source Trial comparisons
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/NCT00074581
GET https://conductscience.org/api/trials/v1/NCT00074581/events?page=2