Clinical trial NCT00514098: Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials
Official title: An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Microbicide
Seroconversion
Treatment Experienced
Treatment Naive
Lead sponsor: Microbicide Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2007-08-09
Enrollment: 479
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are diagnosed with HIV-1 during participation in previous microbicide trials

Brief summary: A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.

Detailed description: It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.

The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.

A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study

Primary outcomes:
measure: HIV disease progression comparison
timeFrame: 12 months
Secondary outcomes:
measure: HIV disease progression comparison
timeFrame: Total duration of follow up
measure: Virologic and immunologic response comparison
timeFrame: Total duration of follow up
measure: HIV-1 drug resistance profile comparison
timeFrame: Total duration of follow up
measure: Sexual behavior and partnership status changes
timeFrame: Total duration of follow up
Other outcomes:
measure: HIV-1 drug resistance mutation evaluation
timeFrame: Total duration of follow up
Locations:
city: Blantyre
country: Malawi
facility: College of Med. JHU CRS
city: Lilongwe
country: Malawi
facility: University of North Carolina Lilongwe
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health Institute (WRHI)
state: Gauteng
city: Johannesburg
country: South Africa
facility: CAPRISA- The Aurum Institute
state: Guateng
city: Durban
country: South Africa
facility: CAPRISA eThewkini
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, Tongaat
state: KwaZulu Natal
city: Durban
country: South Africa
facility: Botha's Hill CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Overport CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Isipingo CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Verulam CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Umkomaas CRS
state: KwaZulu-Natal
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (HPRU)
state: Soweto
city: Durban
country: South Africa
facility: R. K. Khan CRS
city: Kampala
country: Uganda
facility: Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
city: Kamwala
country: Zambia
facility: Kamwala Clinic CRS
city: Harare
country: Zimbabwe
facility: UZ-UCSF HIV Prevention Trials Unit
state: Chitungwiza
city: Chitungwiza
country: Zimbabwe
facility: Seke South CRS
city: Harare
country: Zimbabwe
facility: Spilhaus CRS
Study officials:
affiliation: University of Pittsburgh
name: Sharon A. Riddler, MD
role: STUDY_CHAIR
References:
citation: Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
citation: Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One. 2017 Jun 28;12(6):e0178594. doi: 10.1371/journal.pone.0178594. eCollection 2017.
citation: Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials. 2016 Sep;17(5):204-11. doi: 10.1080/15284336.2016.1212561. Epub 2016 Jul 28.