Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARV-Treated Participants | Those participants who received dapivirine during HIV seroconversion |
| |
| ARV-Naive Participants | Those participants who received placebo during HIV seroconversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Investigational Product | Drug | This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo. | The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion.
This study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Linda-Gail Bekker | Desmond Tutu HIV Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Ubuzima | Kiyovu | Kigali | Rwanda | |||
| Qhakaza Mbokodo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36189636 | Derived | Steytler J, van der Ryst E, Craig C, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; IPM 007 Study Team. Clinical Presentation, Treatment Response, and Virology Outcomes of Women Who Seroconverted in the Dapivirine Vaginal Ring Trials-The Ring Study and DREAM. Clin Infect Dis. 2023 Feb 8;76(3):389-397. doi: 10.1093/cid/ciac804. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ladysmith |
| KwaZulu-Natal |
| South Africa |
| Prevention for HIV and AIDS Project (PHIVA) | Pinetown | KwaZulu-Natal | South Africa |
| Madibeng Centre for Research (MCR) | Brits | 0250 | South Africa |
| Maternal, Adolescent and Child Health (MatCH) | Plessislaer | 3216 | South Africa |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |